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Cited by 129SARS-CoV-2 detection and testingSARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research Studies

The DOI matches its Crossref record; 31 of the 32 references it cites were found in a registry or an index.

Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation

Open access
Oved, Kfir, Olmer, Liraz, Shemer-Avni, Yonat, Wolf, Tamar, Supino-Rosin, Lia, Prajgrod, George, Shenhar, Yotam, Payorsky, Irina, Cohen, Yuval, Kohn, Yishai, Indenbaum, Victoria, Lazar, Rachel, Geylis, Valeria, Oikawa, Michal Tepperberg, Shinar, Eilat, Stoyanov, Evgeniy, Keinan-Boker, Lital, Bassal, Ravit, Reicher, Shay, Yishai, Ruti, Bar-Chaim, Adina, Doolman, Ram, Reiter, Yoram, Mendelson, Ella, Livneh, Zvi, Freedman, Laurence S., Lustig, Yaniv·2020·EClinicalMedicine
DOI 10.1016/j.eclinm.2020.100651PMC PMC7676374
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Abstract

BACKGROUND: An Israeli national taskforce performed a multi-center clinical and analytical validation of seven serology assays to determine their utility and limitations for SARS-CoV-2 diagnosis. METHODS: Serology assays from Roche, Abbott, Diasorin, BioMerieux, Beckman-Coulter, Siemens, and an in-house RBD ELISA were included. Negative samples from 2391 individuals representative of the Israeli population, and 698 SARS-CoV-2 PCR positive patients, collected between March and May 2020, were analyzed. FINDINGS: Immunoassays sensitivities between 81.5%-89.4% and specificities between 97.7%-100% resulted in a profound impact on the expected Positive Predictive Value (PPV) in low (<15%) prevalence scenarios. No meaningful increase was detected in the false positive rate in children compared to adults. A positive correlation between disease severity and antibody titers, and no decrease in antibody titers in the first 8 weeks after PCR positivity was observed. We identified a subgroup of symptomatic SARS-CoV-2 positive patients (~5% of patients), who remained seronegative across a wide range of antigens, isotypes, and technologies. INTERPRETATION: The commercially available automated immunoassays exhibit significant differences in performance and expected PPV in low prevalence scenarios. The low false-positivity rate in under 20's suggests that cross-reactive immunity from previous CoV strains is unlikely to explain the milder disease course in children. Finding no decrease in antibody titers in the first 8 weeks is in contrast to some reports of short half-life for SARS-CoV-2 antibodies. The ~5% who were seronegative non-responders, using multiple assays in a population-wide manner, represents the proportion of patients that may be at risk for re-infection. FUNDING: Israel Ministry of Health.

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Research works printed but not linked: 5

  1. Lustig, 2020, Potential antigenic cross-reactivity between SARS-CoV-2 and dengue viruses, Clin Infect Dis
  2. Lynch, 2020, Magnitude and kinetics of anti-SARS-CoV-2 antibody responses and their relationship to disease severity, Clin Infect Dis
  3. Magid, 2020, Health Ministry announces purchase of 2.4 million antibody tests, Times Israel
  4. Kirkpatrick, 2020, Paid $20 million for new coronavirus tests. They didn't work., New York Times.
  5. To, 2020, COVID-19 re-infection by a phylogenetically distinct SARS-coronavirus-2 strain confirmed by whole genome sequencing, Clin Infect Dis

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Metadata

Authors
Oved, K., Olmer, L., Shemer-Avni, Y., Wolf, T., Supino-Rosin, L., Prajgrod, G., Shenhar, Y., Payorsky, I., Cohen, Y., Kohn, Y., Indenbaum, V., Lazar, R., Geylis, V., Oikawa, M. T., Shinar, E., Stoyanov, E., Keinan-Boker, L., Bassal, R., Reicher, S., Yishai, R., Bar-Chaim, A., Doolman, R., Reiter, Y., Mendelson, E., Livneh, Z., Freedman, L. S., & Lustig, Y.
Affiliations
  • Sheba Medical Center (IL)
  • Maccabi Healthcare Services (IL)
  • Ministry of Defense (IL)
  • Magen David Adom (IL)
  • Israel Ministry of Health (IL)
  • Technion – Israel Institute of Technology (IL)
  • Tel Aviv University (IL)
  • Weizmann Institute of Science (IL)
Corresponding author
Lustig, Yaniv
ORCID
Venue
EClinicalMedicine
Publisher
Elsevier BV
Published
2020-12
Volume
29-30
Pages
100651
ISSN
2589-5370 (ISSN-L)
DOI
10.1016/j.eclinm.2020.100651
PMC
PMC7676374
OpenAlex
W3099879565
Cited by
129
References
32
Citations by year
2026: 1 · 2025: 3 · 2024: 5 · 2023: 14 · 2022: 33 · 2021: 71 · 2020: 1
FWCI
3.90
Type
journal article
Language
en
Open access
Licence
Locations
  • EClinicalMedicine (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Ministry of Health, State of Israel
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Keywords
SARS-CoV-2, immunoassay validation, antibody titers, positive predictive value, low prevalence, children, disease severity, reinfection risk, antibody half-life, immunological cross-reactivity, assay sensitivity and specificity

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